Global Regulatory Strategy Lead — Remote (US-based)

Sarepta Therapeutics; Illinois; Hybrid; USD 116,000 - 145,000; Full time

Job summary

Sarepta Therapeutics seeks a Regulatory Affairs lead to steer clinical trial activities, ensure regulatory submissions, and shape regulatory strategy for multiple markets. The role emphasizes cross-functional collaboration and adherence to Sarepta SOPs.

The position requires 5+ years in regulatory affairs, knowledge of ICH guidelines, IND/CTA experience, and strong communication skills. This is a hybrid, US-based role with onsite work and occasional in-person events.

Qualifications

• Knowledge of drug development and regulatory processes.
• Experience with INDs/CTAs and regulatory submissions.
• Ability to manage multiple projects and communicate effectively.

Responsibilities

• Lead regulatory affairs for clinical trial activities, including CTAs and agency inquiries.
• Review regulatory submissions and CRO materials for Sarepta programs.
• Define regulatory strategy for assigned markets and ensure timely submissions.
• Maintain documentation compliant with Sarepta SOPs and regulatory expectations.
• Collaborate with Global Regulatory Lead and cross-functional teams to enable product lifecycle activities.

Skills

Regulatory affairs

ICH guidelines

IND/CTA submissions

Multi-tasking & project management

Cross-functional collaboration

Microsoft Office

Education

BS or equivalent in life sciences

MS in Regulatory Affairs or RAC

Tools

Microsoft Word/Excel

Job description

Sarepta Therapeutics seeks a Regulatory Affairs lead to steer clinical trial activities, ensure regulatory submissions, and shape regulatory strategy for multiple markets. The role emphasizes cross-functional collaboration and adherence to Sarepta SOPs.

The position requires 5+ years in regulatory affairs, knowledge of ICH guidelines, IND/CTA experience, and strong communication skills. This is a hybrid, US-based role with onsite work and occasional in-person events.